Source: Rheumatologia  |  Posted 9 years ago

By Alison Palkhivala

PHILADELPHIA, PA -- May 22, 2002 -- New research demonstrates that sertraline is effective for the treatment of generalized social anxiety disorder.

Sertraline is already indicated for the treatment of depression, post-traumatic stress disorder, panic disorder, and obsessive-compulsive disorder.

Michael R. Liebowitz, MD, director of the anxiety disorders clinic at the New York State Psychiatric Institute and professor of clinical psychiatry at Columbia College of Physicians and Surgeons in New York, New York, presented the study here this week at the American Psychiatric Association meeting.

The double-blind, placebo-controlled, multicenter study, randomized 415 outpatients with generalized social anxiety disorder to treatment with the selective serotonin reuptake inhibitor (SSRI) sertraline in a flexible dose schedule of 50 mg to 200 mg or placebo for 12 weeks.

Participants had a mean baseline score of 93 on the Liebowitz Social Anxiety Scale (LSAS), which represents moderate to severe social anxiety. They also had a mean Clinical Global Impression-Severity scale (CGI-S) score of 4.8.

At the end of the trial, reductions in LSAS scores were significantly greater for patients in the sertraline group compared to patients in the placebo group (reduction of 35.0 vs. 21.4 points, respectively, p<0.001). Furthermore, 55.6 percent of patients on sertraline had Clinical Global Impression-Improvement scale (CGI-I) scores less than or equal to ?2? (much or very much improved) compared to only 29.5 percent on placebo (p<0.001).

On quality of life and general functioning measurements, the sertraline group was also found to be better off than the placebo group. Sertraline was well tolerated, with discontinuation rates approaching that of placebo.

Pfizer Inc., makers of sertraline under the trade name Zoloft, filed a supplemental new drug application with the US Food and Drug Administration (FDA) in January of 2002. They are requesting that the drug receive an official indication for the treatment of social phobia.